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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P170043 / PAS002 |
| Date Original Protocol Accepted |
04/16/2019
|
| Date Current Protocol Accepted |
03/03/2021
|
| Study Name |
New Enrollment PAS
|
| Device Name |
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
|
| Clinical Trial Number(s) |
NCT01461291
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this post approval study (PAS) is to evaluate the rate of clinically relevant complications associated with iStent inject
placement and stability, as determined at 36 months in the postmarket setting compared to the pre-specified performance
target of 2%. This is a prospective, non-randomized, multicenter, single-arm, post approval study of the iStent inject with follow-up
through 3 years postoperative.
|
| Study Population |
358 eyes at a minimum of 15 and up to 30 investigational sites in the U.S. It is expected that the enrollment phase will last up to 37.5
months.
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| Sample Size |
A sample size of 250 eyes can provide a statistical power of 80% at a true p of 0.05. Considering a drop-out rate of 30% at 36 months for
this post-approval study, the study should treat at least 358 eyes of 358 subjects.
|
| Key Study Endpoints |
The rate of clinically relevant complications associated with iStent inject placement and stability as determined at 36 months.
Specific device-related complications include clinical sequelae resulting from device position including, but not limited to:
Secondary surgical intervention (SSI) to modify device position (e.g., repositioning or explantation)
Corneal endothelial touch by device
Corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit, in comparison with preoperative BSCVA
Other Safety Outcomes:
Rate of occurrence of sight-threatening adverse events including:
Persistent (at time of study exit) BSCVA loss greater than or equal to 3 lines compared to best recorded BSCVA at any postoperative visit
Endophthalmitis
Corneal decompensation
Retinal detachment
Severe choroidal hemorrhage or detachment or aqueous misdirection
Rate of ocular secondary surgical interventions (SSI)
Rate of other adverse events including:
Increase from baseline IOP of greater than or equal to 10 mmHg at any time greater than or equal to 30 days postoperative
BSCVA loss greater than or equal to 2 lines at Month 36 compared to preoperative
BSCVA loss greater than or equal to 2 lines at Month 36 compared to best recorded
BSCVA at any postoperative visit
Device movement, defined as a stent not visible in the original location, that does not result in clinically relevant complications
as described above (e.g., SSI to modify device position, corneal endothelial touch by device, or corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit compared to preoperative BSCVA), and that is not attributable to any one or more of the following:
variations in gonioscopy, OCT or UBM (or other standard imaging methods) viewing angle or illumination
changes in angle anatomy due to concomitant findings such as resolution of hyphema
changes in anterior chamber depth
development of focal peripheral anterior synechiae (PAS)
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| Follow-up Visits and Length of Follow-up |
36 months (3 years)
|
| Interim or Final Data Summary |
| Interim Results |
Of the 387 subjects enrolled, 19 subjects were a screen failure, and 367 subjects underwent implantation with the study device at the time of data cutoff. Enrollment accrual is complete, and the last subject was treated on June 23, 2022.
A total of 139 postoperative study eye AEs were reported in 95/367 (25.9%) subjects. The most common AE was dry eye (18 events reported in 18 subjects; 4.9%). There were no reports of intraoperative ocular AEs or UADEs.
At Month 12, 97.4% (342/351) of subjects had Best Spectacle Corrected Visual Acuity (BCVA) of 20/40 or better, and 86.0% (302/351) were 20/25 or better. 64/366 (17.5%) subjects had BSCVA worse than 20/40 preoperatively. 9/351 subjects had visual acuity worse than 20/40 at their last available visit prior to data cutoff, which includes 8 subjects with preoperative BSCVA worse than 20/40.
Additionally, mild corneal edema was observed in 5 eyes at Month 1, and 1 eye had mild corneal edema at Month 12. There were no reports of moderate or severe corneal edema after the Day 1 visit. Observations involving 2+, 3+, and 4+ anterior chamber (AC) cells were limited to postoperative Day 1 and Week 1. 1+ AC cells were reported in 2 eyes at Month 1, 1 eye at Month 3, and 1 eye at Month 6; these 4 subjects had reports of inflammation.
Postoperative goniosynechiae were reported in 7/367 subjects (6 by the same PI). 4/367 subjects had transient postoperative angle abnormalities. Visual Field Mean Deviation (MD) measurements showed a worsening of greater than or equal to 2.5 dB was reported in 6.9% of eyes (24/350) at the Month 12 visit.
Lastly, a total of 182 protocol deviations were reported for 144 /367 subjects. The total rate of protocol deviations was 0.0628%.
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| Actual Number of Patients Enrolled |
387
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| Actual Number of Sites Enrolled |
14
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| Patient Follow-up Rate |
Accountability rates were 97.8% at Month 6, 97.5% at Month 12, and 95.4% at Month 24.
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